🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06079281
Active, not recruiting Phase 3

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

NCT06079281 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-01-03
Last updated
2026-06-22

Condition(s) studied

Hypophosphatasia

Investigational drug(s) / intervention(s)

ALXN1850Placebo

ALXN1850: ALXN1850 will be administered via subcutaneous (SC) injection.

Placebo: Placebo will be administered via SC injection.

Study summary

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

Eligibility

Sex
ALL
Min age
12 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of HPP documented in the medical records * Must meet 1 of the following criteria: 1. Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified laboratory (Section 8.7 ) 2. Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations) * Must meet 1 of the following criteria without a probably cause other than HPP: 1. Serum ALP activity below the age- and sex-adjusted normal range during the screening period as measured by the Central Laboratory 2. Two documented serum ALP activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the Day 1 Visit. Note: Local laboratories need to be CLIA or ISO 15189 certified, or have other local equivalent laboratory certification with Alexion's approval. * Two separate 6MWTs at below 85% of the predicted distance (for age, sex, weight, and height) during the Screening Period without a probable cause other than HPP Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator * Diagnosis of primary or secondary hyperparathyroidism * Hypoparathyroidism, unless secondary to HPP * Any new fracture within 12 weeks before Day 1 (excluding pseudofractures) * Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period * History of allergy or hypersensitivity to any ingredient contained in ALXN1850 or the placebo comparator (Table 9)

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Research Site Indianapolis Indiana
Research Site Garden City New York
Research Site Durham North Carolina
Research Site Columbus Ohio
Research Site Nashville Tennessee
Research Site Ciudad de Buenos Aires Argentina
Research Site Clayton Australia
Research Site Herston Australia
Research Site Parkville Australia
Research Site St Leonards Australia
Research Site Belo Horizonte Brazil
Research Site Brasília Brazil
Research Site Recife Brazil
Research Site Salvador Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Calgary Alberta
Research Site Edmonton Alberta
Research Site Winnepeg Manitoba
Research Site Oakville Ontario
Research Site Trois-Rivières Quebec
Research Site Beijing China
Research Site Beijing China
Research Site Changsha China
Research Site Chengdu China
Research Site Nanchang China
Research Site Qingdao China
Research Site Shanghai China
Research Site Shenzhen China
Research Site Paris France
Research Site Poitiers France
Research Site Bad Reichenhall Germany
Research Site Berlin Germany
Research Site Bonn Germany
Research Site Hamburg Germany
Research Site Würzburg Germany
Research Site Ashkelon Israel
Research Site Ramat Gan Israel
Research Site Florence Italy
Research Site Milan Italy

+ 25 more sites — see the full list on the official registry below.

More Alexion Pharmaceuticals, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079281 on ClinicalTrials.gov ↗ ← All trials in the UK